Tepezza

What Is Tepezza?

Tepezza (teprotumumab-trbw) is an insulin-like growth factor-1 receptor inhibitor used to treat Thyroid Eye disease.

What Are Side Effects of Tepezza?

Side effects of Tepezza include:

• muscle spasm,
• nausea,
• hair loss,
• diarrhea,
• fatigue,
• high blood sugar (hyperglycemia),
• hearing impairment,
• dry skin,
• changes in taste, and
• headache

Dosage for Tepezza

The initial dose of Tepezza is 10 mg/kg for the first infusion, followed by 20 mg/kg every 3 weeks for 7 additional infusions. Tepezza is administered by intravenous infusion over 60 to 90 minutes.

Tepezza In Children

The safety and effectiveness of Tepezza have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Tepezza?

Tepezza may interact with other medicines.

Tell your doctor all medications and supplements you use.

Tepezza During Pregnancy and Breastfeeding

Tepezza is not recommended for use during pregnancy; it may harm a fetus. Appropriate forms of contraception should be implemented prior to initiation, during treatment, and for 6 months following the last dose of Tepezza. It is unknown if Tepezza passes into breast milk or how it would affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Tepezza (teprotumumab-trbw) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Tepezza Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during an injection or within 1.5 hours afterward. Tell your caregiver if you feel hot, anxious, or short of breath, or if you have a headache, muscle pain, or fast heartbeats.

Call your doctor at once if you have:

• diarrhea (with or without blood);
• stomach cramps;
• bowel movements that occur suddenly;
• loss of bowel control;
• a feeling of not completely emptying your bowels;
• rectal bleeding; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects may include:

• muscle spasms;
• nausea, diarrhea;
• headache, tiredness;
• high blood sugar;
• hair loss;
• hearing problems;
• dry skin; or
• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tepezza (Teprotumumab-trbw for Injection, for Intravenous Use)

 

Tepezza Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Infusion Reactions [see WARNINGS AND PRECAUTIONS]
• Exacerbation of Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
• Hyperglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of TEPEZZA was evaluated in two randomized, double-masked, placebo-controlled clinical studies (Study 1 [NCT:01868997] and Study 2 [NCT:03298867]) consisting of 170 patients with Thyroid Eye Disease (84 received TEPEZZA and 86 received placebo). Patients were treated with TEPEZZA (10 mg/kg for first infusion and 20 mg/kg for the remaining 7 infusions) or placebo given as an intravenous infusion every 3 weeks for a total of 8 infusions. The majority of patients completed 8 infusions (89% of TEPEZZA patients and 93% of placebo patients).

The most common adverse reactions (≥5%) that occurred at greater incidence in the TEPEZZA group than in the control group during the treatment period of Studies 1 and 2 are summarized in Table 1.

Table 1: Adverse Reactions Occurring in 5% or More of Patients Treated with TEPEZZA and Greater Incidence than Placebo

Adverse Reactions	TEPEZZA N=84 N (%)	Placebo N=86 N (%)
Muscle spasms	21 (25%)	6 (7%)
Nausea	14 (17%)	8 (9%)
Alopecia	11 (13%)	7 (8%)
Diarrhea	10 (12%)	7 (8%)
Fatiguea	10 (12%)	6 (7%)
Hyperglycemiab	8 (10%)	1 (1%)
Hearing impairmentc	8 (10%)	0
Dysgeusia	7 (8%)	0
Headache	7 (8%)	6 (7%)
Dry skin	7 (8%)	0
a Fatigue includes asthenia b Hyperglycemia includes blood glucose increase c Hearing impairment (includes deafness, eustachian tube dysfunction, hyperacusis, hypoacusis and autophony)

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

In a placebo-controlled study with TEPEZZA, 1 of 42 patients treated with placebo had detectable levels of antidrug antibodies in serum. In the same study, none of the 41 patients treated with TEPEZZA had detectable levels of antidrug antibodies in serum.

Read the entire FDA prescribing information for Tepezza (Teprotumumab-trbw for Injection, for Intravenous Use)